BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 5350134 · Received January 7, 2016

    Report

    Report Number
    1828100-2016-00008
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Date of Event
    December 15, 2015
    Report Date
    March 10, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Removal / Correction Number
    1828100-06/05/2007-005-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD SERVICE REPRESENTATIVE (FSR) MENTIONED THAT THE CUSTOMER EXPERIENCED A SIMILAR ISSUE BUT NEVER CALLED THE COMPLAINT INTO THE MANUFACTURER. THE FSR WAS ABLE TO REPLICATE THE ISSUE UPON TESTING THE MONITOR.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. DURING THE LABORATORY EVALUATION, THE PRODUCT SURVEILLANCE TECHNICIAN (PST) OBSERVED A GRAY DISTORTED DISPLAY. THE ISSUE WAS ISOLATED TO A DEFECTIVE FPINC (FLAT PANEL INTERFACE NODE CONTROLLER) CABLE IN THE CENTRAL CONTROL MONITOR (CCM). MECHANICAL AGITATION OF THE BOARD CAUSED THE DISPLAY TO INTERMITTENTLY FUNCTION CORRECTLY. THE CONNECTORS AND CONTACTS WERE CLEANED BUT THIS DID NOT ALLEVIATE THE ISSUE. REPLACEMENT OF CUSTOMER FPINC BOARD WITH THE LAB-USE ONLY (LUO) FPINC BOARD RESTORED THE (CCM) FUNCTIONALITY DETERMINING THE CUSTOMER FPINC BOARD WAS DEFECTIVE. THE PRODUCT WILL BE SENT TO SERVICE TO BE BROUGHT TO MANUFACTURERS SPECIFICATIONS BEFORE BEING RETURNED TO THE CUSTOMER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THERE WAS A SCREEN FAILURE ON THE QUANTUM CONTROL UNIT (QCU), AS THE SCREEN WAS UNRESPONSIVE (GRAYS OUT). THE DEVICE WAS NOT CHANGED OUT, AS THE SURGEON WENT ON TO MANUAL CONTROL AND FINISHED THE CASE. THERE WAS NO DELAY AND NO BLOOD LOSS. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: PER FOLLOW-UP ON (B)(4)-2106: THE PERFUSIONIST (CCP) STATED THAT THEY REBOOTED THE BASE, HARD RESET AND THE MONITOR CAME BACK ON. THEY FINISHED THE CASE WITH NO FURTHER ISSUES. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10822 TERUMO ADVANCED PERFUSION SYSTEM 1 CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 802100

    Patients

    Seq Age Sex Outcome Treatment
    1